Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2025-12-24 @ 5:21 PM
NCT ID:
NCT00193050
Eligibility Criteria:
Inclusion Criteria:
To be included in this study, you must meet the following criteria:
* Adenocarcinoma of the breast confirmed by biopsy
* Female Patients \>18 years of age
* Normal cardiac function
* Ability to perform activities of daily living with minimal assistance
* Chemotherapy naïve or have received prior chemotherapy \> 5 years ago
* Adequate bone marrow, liver and kidney function
* Be informed of the investigational nature of this study
* Sign an informed consent form
* Sentinel lymph node and/or axillary dissection prior to enrollment
Exclusion Criteria:
You cannot participate in this study if any of the following apply to you:
* Life expectancy of \< than 6 months
* History of significant heart disease
* Prior chemotherapy or hormonal therapy
* Concurrent Trastuzumab therapy
* History of significant psychiatric disorders
* History of active uncontrolled infection
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00193050
Study Brief:
Protocol Section:
NCT00193050